Omega 3 Supplementation in Fatty Liver

NCT01992809 | Completed Phase 3 DMC

• 1 other identifier: 0681/09CAPPESQ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is a clinical and pathological condition, whose spectrum can range from steatosis to steatohepatitis and cirrhosis, in patients without a history of alcohol abuse. Nonalcoholic steatohepatitis (NASH), the severe form of (NAFLD), has emerged as a clinically important type of chronic liver disease in industrialized countries and is characterized pathologically by hepatocellular ballooning, Mallory's hyaline, scattered inflammation and perisinusoidal fibrosis. NASH associated with cirrhosis can decompensate into subacute liver failure, progress to hepatocellular cancer and reoccur post transplantation.In the absence of established treatment, therapy is generally directed to treatment of risk factors for metabolic syndrome. Recently, some studies have been demonstrated that Polyunsaturated fatty acids (PUFAs), omega3 type, could reduced TNFalfa, IL6, aminotransferases, insulin resistance and steatosis verified by ultrasound. Neverthless, this is the first study that evaluate liver histology after six months of PUFA (omega3) in the treatment of patients with NASH.

Conditions

Fatty Liver

Keywords

Nonalcoholic fatty liver; omega 3

Outcome Measures

Primary Outcomes (1)

• Efficacy in reduce inflammatory component of NASH for NAS score

  Determine the efficacy of Omega-3 fatty acid in reducing the inflammatory component of NASH for liver through liver biopsy NAS score.

  6 months

Secondary Outcomes (1)

• Inflammatory systemic profile

  6 mothns

Study Arms (2)

Omega 3

ACTIVE COMPARATOR

Omega-3 group (n=30) received capsules containing 945 mg of Omega-3 PUFA \[α linolenic acid/ 64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%\], in 3 capsules/ day

Dietary Supplement: Omega 3

placebo mineral oil

PLACEBO COMPARATOR

placebo mineral oil 3 ml/day

Interventions

Omega 3 DIETARY_SUPPLEMENT

Omega-3 group (n=30) received capsules containing 945 mg of Omega-3 PUFA \[α linolenic acid/ 64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%\], in 3 capsules/ day

Omega 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, both sexes
• With or without non-insulin-dependent diabetes or glucose intolerance
• Absence of alcoholism \<20g (women) and \<40g (men) of ethanol/day, drugs, schistosomiasis, hepatitis B or C and other chronic liver diseases cause determined
• Absence of autoantibodies and rates of copper and ceruloplasmin normal
• Biopsy-liver until 12 months previous, showing steatosis, lobular inflammatory infiltrate and ballooning of hepatocytes, which may be present or not Mallory's corpuscles and liver fibrosis stage I and II, NAS score\> 5;
• Patients who agree to participate in the study and all signed informed consent.

You may not qualify if:

• Poisoning by exogenous oxidants
• Pregnancy and lactation
• Prothrombin time \<70% or platelet count \<70 000/mm3, or any bleeding disorders, including alteration of the bleeding time
• Refusal to cooperate with research
• steatosis without signs of inflammation or ballooning or cirrhosis (stage IV)
• diabetes mellitus using insulin
• allergy to fish or flaxseed
• anti-inflammatory use of non-hormonal

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo School of Medicine

São Paulo, São Paulo, 01246903, Brazil

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• CLAUDIA PM OLIVEIRA, MD, PhD

  University of Sao Paulo, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

BR (1)